To find the effects of Acapella and positive end expiratory pressure device on pulmonary
function test, cough maneuver, sputum diary and dyspnea in post-operative laparoscopic
patients.
Design
Two parallel group , Double blinded, randomized clinical trial with pre and post assessment
Settings and conduct
Surgical Ward/Intensive Care Unit Services Hospital Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age criteria of 35-55yrs
Patients undergone Laparoscopic Surgery (Cholecystectomy, Liver Biopsy, Ectopic Pregnancy, Splenectomy, and Ovarioectomy).
Both male and female
Exclusion Criteria:
Patients body mass index < 15 kg.m-2 or > 30 kg.m-2
Patient’s history of respiratory tract infection within three months
Patient’s baseline arterial partial pressure of oxygen (PaO2) < 70 mmHg or arterial partial pressure of carbon dioxide (PaCO2) > 50 mmHg; baseline forced expiratory volume in 1 s (FEV1) < 30% of predicted.
Intervention groups
Laparoscopic Surgery Patients using Acapella and Positive End Expiratory Pressure Device.
Main outcome variables
Dyspnea will be checked by Multidimensional Dyspnea Profile (MDP)
Sputum Diary will be checked by Breathlessness, Cough, Sputum Scale (BCSS)
Pulmonary Function Test will be checked by Spirometer and following four readings will be taken FVC, FEV1, FVC/FEV1, PEFR
General information
Reason for update
Acronym
CEAPEPPLS
IRCT registration information
IRCT registration number:IRCT20191117045462N9
Registration date:2023-11-08, 1402/08/17
Registration timing:registered_while_recruiting
Last update:2023-11-08, 1402/08/17
Update count:0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-01-31, 1402/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effects of Acapella and Positive End Expiratory Pressure Device among Patients with Laparoscopic Surgery
Public title
Comparative Effects of Acapella and Positive End Expiratory Pressure Device among Patients with Laparoscopic Surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age criteria of 35-55yrs
Patients undergone Laparoscopic Surgery (Cholecystectomy, Liver Biopsy, Ectopic Pregnancy, Splenectomy, and Ovarioectomy)
Both male and female
Exclusion criteria:
Patients body mass index < 15 kg.m-2 or > 30 kg.m-2
Patient’s history of respiratory tract infection within three months
Patient’s baseline arterial partial pressure of oxygen (PaO2) < 70 mmHg or arterial partial pressure of carbon dioxide (PaCO2) > 50 mmHg; baseline forced expiratory volume in 1 s (FEV1) < 30% of predicted.
Age
From 35 years old to 55 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be recruited by Convenient sampling technique and then then patients will be divided into two groups by simple random sampling through sealed opaque enveloped.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both participants and outcome assessor will be blind. Assessment will be done by another therapist who will not be involved in treatment and data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore.
City
Lahore
Postal code
5400
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
REC/RCR & AHS/23/0328
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other specified parts of digestive tract
2
Description of health condition studied
Splenectomy
ICD-10 code
D73.0
ICD-10 code description
Hyposplenism
Primary outcomes
1
Description
Dyspnea
Timepoint
Pre post treatment
Method of measurement
will be checked by Multidimensional Dyspnea Profile (MDP)
2
Description
Sputum Diary
Timepoint
pre post treatment
Method of measurement
Breathlessness, Cough, Sputum Scale (BCSS)
3
Description
Pulmonary Function Test
Timepoint
pre post treatment
Method of measurement
portable spirometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Laparoscopic Surgery patients using Acapella
Category
Treatment - Devices
2
Description
Intervention group: Laparoscopic Surgery patients using Positive End Expiratory Pressure Device
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Riphah college of rehabilitation & Allied Health Sciences
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore.
City
Lahore
Postal code
54000
Phone
+92 301 7983537
Email
kareenakhan107@gmail.com
Web page address
https://www.riphah.edu.pk
2
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Kareena Imran
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore.
City
Lahore
Postal code
54000
Phone
+92 301 7983537
Email
kareenakhan107@gmail.com
Web page address
https://www.riphah.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore.
City
Lahore
Postal code
54000
Phone
+92 323 4500788
Email
wajeeha_z@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Kareena Imran
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 301 7983537
Email
kareenakhan107@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore.
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 323 4500788
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Kareena Imran
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 301 7983537
Email
kareenakhan107@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available